Results of a phase II study of vorinostat in combination with intravenous fludarabine, mitoxantrone, and dexamethasone in patients with relapsed or refractory mantle cell lymphoma: an interim analysis

Shin, Dong Yeop; Kim, Seok Jin; Yoon, Dok Hyun; Park, Yong; Kong, Jee Hyun; Kim, Jeong‐A; Kim, Byung Su; Kim, Hyo Jung; Won, Jong Ho; Park, Sung Kyu; Kim, Won Seog

doi:10.1007/s00280-016-3005-y

Cited by 10 publications

(8 citation statements)

References 48 publications

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“…In 2012, a phase II study for vorinostat combined with fludarabine, mitoxantrone, and dexamethasone (V-FND) in patients with relapsed or refractory MCL was conducted and resulted in 77.8% ORR and 9.3 months median PFS (CISL 1201). We concluded that V-FND is an effective regimen for relapsed or refractory MCL; however, significant hematologic adverse events including neutropenia (grade 3/4 in 50%) and thrombocytopenia (grade 3/4 in 35%) were not negligible [52].…”

Section: Other Subtypes Of B-cell Neoplasmsmentioning

confidence: 79%

Lymphoma epidemiology in Korea and the real clinical field including the Consortium for Improving Survival of Lymphoma (CISL) trial

Yoo

Lee²,

Suh

et al. 2018

Int J Hematol

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Lymphomas are a heterogeneous group of disease entities with well-defined clinical, morphological, immunophenotypic, and cytogenetic characteristics. Moreover, regional and racial differences have been reported in their incidence and subtype compositions. Here, we reviewed the epidemiology of lymphomas and summarized the recent achievements in specific subtypes prevalent in Korean population, focusing on clinical studies conducted by the Consortium for Improving Survival of Lymphoma (CISL) of the Korean Society of Hematology Lymphoma Working Party (KSH-LWP).

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Section: Other Subtypes Of B-cell Neoplasmsmentioning

confidence: 79%

Lymphoma epidemiology in Korea and the real clinical field including the Consortium for Improving Survival of Lymphoma (CISL) trial

Yoo

Lee²,

Suh

et al. 2018

Int J Hematol

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“…Histone-deacetylase (HDAC) inhibitors belong to innovative anticancer drugs. Unfortunately, HDAC inhibitors tested so far (vorinostat, panobinostat, and abexinostat), single-agent or in combination with various anti-lymphoma drugs, demonstrated modest anti-MCL efficacy in clinical trials published so far [60,61,62,63,64]. Mutations in SMARCA4 have been associated with poor response to ibrutinib plus venetoclax therapy through upregulation of BCL2L1/BCL-XL [65].…”

Section: Recurrent Molecular/cytogenetic Lesionsmentioning

confidence: 99%

Advances in Molecular Biology and Targeted Therapy of Mantle Cell Lymphoma

Klener

2019

IJMS

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Mantle cell lymphoma (MCL) is a heterogeneous malignancy with a broad spectrum of clinical behavior from indolent to highly aggressive cases. Despite the fact that MCL remains in most cases incurable by currently applied immunochemotherapy, our increasing knowledge on the biology of MCL in the last two decades has led to the design, testing, and approval of several innovative agents that dramatically changed the treatment landscape for MCL patients. Most importantly, the implementation of new drugs and novel treatment algorithms into clinical practice has successfully translated into improved outcomes of MCL patients not only in the clinical trials, but also in real life. This review focuses on recent advances in our understanding of the pathogenesis of MCL, and provides a brief survey of currently used treatment options with special focus on mode of action of selected innovative anti-lymphoma molecules. Finally, it outlines future perspectives of patient management with progressive shift from generally applied immunotherapy toward risk-stratified, patient-tailored protocols that would implement innovative agents and/or procedures with the ultimate goal to eradicate the lymphoma and cure the patient.

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“…Only five HRQoL studies were identified for inclusion in the review: three phase II single-arm trials [28][29][30], one publication of patient-reported outcomes in a phase III randomized controlled trial (RCT) (MCL-3001) [31], and one retrospective observational study [24]. Two studies were conducted in the US [28,29], one each in the Republic of Korea [30] and Switzerland [24], and one was multinational [31]. All five used cancer-specific (EORTC QLQ-C30 or FACT-G) or lymphoma-specific (FACT-Lym) instruments.…”

Section: Health-related Quality Of Lifementioning

confidence: 99%

Systematic Literature Review of Economic Evaluations, Costs/Resource Use, and Quality of Life in Patients with Mantle Cell Lymphoma

Monga¹,

Garside

Davids

et al. 2020

PharmacoEconomics Open

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Background Mantle cell lymphoma (MCL) is a rare and aggressive subtype of non-Hodgkin's lymphoma. While treatment of patients with MCL and their outcomes are previously published, the availability of heath economics evidence is unclear. Objective The aim of this paper was to conduct a comprehensive review of studies relating to economic evaluations, costs and resource use, and health-related quality of life (HRQoL) in patients with MCL. Methods Search strategies were designed to capture studies reporting economic or HRQoL outcomes published in the previous 11 years (2007-2018). The following electronic databases were searched: MEDLINE, Embase, NHS Economic Evaluation Database (NHS EED), and EconLit. In addition, we reviewed congress abstracts presented over the previous 2 years (2015 and 2016; where 2017 proceedings had occurred, these were searched instead of 2015). Publications were screened in duplicate by two reviewers and supplementary searches were carried out on health technology assessment websites. Searches were first conducted in October 2017 and updated in March 2018. Findings The systematic literature review identified 11 economic evaluations (in 16 publications), seven studies reporting data relating to costs or resource use, and five relating to HRQoL. Four economic evaluations presented results for patients with MCL modelled in the first-line setting, while seven modelled patients in the relapsed/refractory setting. The majority of economic evaluations were conducted using a Markov model with three to five health states. Seven studies assessed resource use and reported adverse events as key drivers of increased costs and resource use. Across the five studies reporting HRQoL, disparate measures were used. Two studies reported improvement in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) total scores following treatment and found that clinical response to treatment was associated with improvement in overall HRQoL. Conclusions and Relevance The published economic and HRQoL evidence in MCL, although scarce, reveals that the economic and HRQoL burden associated with MCL is substantial. In highlighting this evidence, this analysis underlines a critical unmet need for more effective treatments with improved outcomes in MCL.

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Results of a phase II study of vorinostat in combination with intravenous fludarabine, mitoxantrone, and dexamethasone in patients with relapsed or refractory mantle cell lymphoma: an interim analysis

Abstract: V-FND is effective in patients with relapsed or refractory MCL. However, significant toxicities were hurdles to sustained V-FND therapy.

Cited by 10 publications

References 48 publications

Lymphoma epidemiology in Korea and the real clinical field including the Consortium for Improving Survival of Lymphoma (CISL) trial

Lymphoma epidemiology in Korea and the real clinical field including the Consortium for Improving Survival of Lymphoma (CISL) trial

Advances in Molecular Biology and Targeted Therapy of Mantle Cell Lymphoma

Systematic Literature Review of Economic Evaluations, Costs/Resource Use, and Quality of Life in Patients with Mantle Cell Lymphoma

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